European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. The second was crofelemer, Mytesi , an indicator drug for HIV-associated diarrhoea extracted from the blood-red latex of the South American croton tree. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

FDA Law Blog: Biosimilars

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R.

Documentation 52

Documentation Labelling 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. 8,128,929 [] for [PTE] request under 35 U.S.C. §

Documentation 59

Documentation 59

FDA Law Blog: Biosimilars

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. If there is a change in administration, this process will almost surely be halted immediately, unless the current administration abandons the effort on its own, as it did in 2016 (see post here ).

Documentation 56

Documentation 56

FDA Law Blog: Biosimilars

JANUARY 30, 2025

Claud During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications , my thoughts turned to the principles underlying the Freedom of Information Act (FOIA). Since its enactment, Congress has strengthened FOIAs disclosure provisions, most recently in 2016.

Communication 66

Communication Documentation 66

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

Documentation 113

Documentation Labelling 113

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

Documentation 64

Documentation Drug Development 64

FDA Law Blog: Biosimilars

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

Documentation 59

Documentation 59